Probiotics for Quality of Life in Autism Spectrum Disorders
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Anxiety, Neurology, Psychiatric, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 3 - 12 |
| Updated: | 12/16/2017 |
| Start Date: | August 2016 |
| End Date: | December 1, 2017 |
The physical and mental/emotional health of people with autism spectrum disorder (ASD) are
closely connected. The emerging data on immune abnormalities and gut microbiome differences,
and interactions of the genome with these suggest a possible etiological link between
physical and mental dysfunction, especially the gastrointestinal (GI) dysfunction and severe
anxiety that many individuals with ASD manifest. The investigators have preliminary clinical
evidence that children with ASD & GI symptoms differ in microbiome composition and function
from neurotypical children with GI symptoms. The investigators hypothesize that altered
host-microbial signals, which include altered fecal neurotransmitter gamma-aminobutyric acid
(GABA) levels contribute towards anxiety and sensory over-responsivity in ASD. Our
preliminary findings also show that probiotic Visbiome Extra Strength, improves GI and pain
symptoms, correlating with altered gut microbiome composition and related metabolites (the
macrobiome). The proposed crossover trial will explore the possibilities of this new
appreciation of the microbiome-mental/physical function connection for ASD, GI dysfunction,
and anxiety. If altering the gut microbiome results in better GI and emotional function, it
could improve the quality of life for children with ASD and their parents. A pilot trial with
12 children with ASD will test feasibility for a proposed three-site crossover randomized
clinical trial (RCT) of probiotics (beneficial bacteria including Lactobacilli &
Bifidobacteria) in 60 children 3-12 years old with ASD, GI dysfunction, & anxiety. In a
balanced crossover children will be randomized 1;1 to Visbiome or placebo first, 8 weeks per
condition with 3 weeks washout between. The investigators have access to significant fecal
microbiome and metabolome data from NIH-funded Human Microbiome Projects (HMP) on similar-age
healthy and irritable-bowel children, with and without ASD. These will help leverage our
understanding of macrobiome changes that correlate with functional improvement of GI and
abdominal pain symptoms. Pilot study efficiency will also benefit from those HMPs having
already collected and analyzed baseline stools for some children with ASD, thus saving
significant costs for baseline stool analyses for the pilot.
closely connected. The emerging data on immune abnormalities and gut microbiome differences,
and interactions of the genome with these suggest a possible etiological link between
physical and mental dysfunction, especially the gastrointestinal (GI) dysfunction and severe
anxiety that many individuals with ASD manifest. The investigators have preliminary clinical
evidence that children with ASD & GI symptoms differ in microbiome composition and function
from neurotypical children with GI symptoms. The investigators hypothesize that altered
host-microbial signals, which include altered fecal neurotransmitter gamma-aminobutyric acid
(GABA) levels contribute towards anxiety and sensory over-responsivity in ASD. Our
preliminary findings also show that probiotic Visbiome Extra Strength, improves GI and pain
symptoms, correlating with altered gut microbiome composition and related metabolites (the
macrobiome). The proposed crossover trial will explore the possibilities of this new
appreciation of the microbiome-mental/physical function connection for ASD, GI dysfunction,
and anxiety. If altering the gut microbiome results in better GI and emotional function, it
could improve the quality of life for children with ASD and their parents. A pilot trial with
12 children with ASD will test feasibility for a proposed three-site crossover randomized
clinical trial (RCT) of probiotics (beneficial bacteria including Lactobacilli &
Bifidobacteria) in 60 children 3-12 years old with ASD, GI dysfunction, & anxiety. In a
balanced crossover children will be randomized 1;1 to Visbiome or placebo first, 8 weeks per
condition with 3 weeks washout between. The investigators have access to significant fecal
microbiome and metabolome data from NIH-funded Human Microbiome Projects (HMP) on similar-age
healthy and irritable-bowel children, with and without ASD. These will help leverage our
understanding of macrobiome changes that correlate with functional improvement of GI and
abdominal pain symptoms. Pilot study efficiency will also benefit from those HMPs having
already collected and analyzed baseline stools for some children with ASD, thus saving
significant costs for baseline stool analyses for the pilot.
Inclusion Criteria:
1. have DSM-5 ASD on clinical evaluation by a doctoral-level diagnostician, confirmed by
Autism Diagnostic Interview-Revised or Autism Diagnostic Observation Schedule;
2. be between 3 and 12 years old;
3. have >2 mo. abdominal pain, constipation, diarrhea, and/or vomiting, with an item-mean
score >2 on at least one scale of the GI module of the PedsQL scale;
4. have clinical anxiety symptoms with an item mean of >1.0 (0-3 scale) on the new Autism
Anxiety Scale.
Participants will be recruited from minority, poor, inner city, or rural populations.
Exclusion Criteria:
1. Antibiotics in 2 months prior to enrolling;
2. Prior bowel surgery;
3. Chronic serious medical condition (e.g., diabetes);
4. Weight or height < 3rd %ile for age;
5. Chronic anti-inflammatory use within 2 months prior to enrolling;
6. History of inflammatory bowel disease, Celiac disease, or eosinophilic disorders
(e.g., eosinophilic esophagitis);
7. Already taking probiotics within the previous 6 months.
We found this trial at
1
site
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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